Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

MK0518 400 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Placebo

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Participant Flow for 3 periods

Period 1: Double-Blind (DB)

MK0518 200 mg b.i.d.

MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

Placebo

STARTED

44

45

45

45

Treated

43

45

45

45

COMPLETED

30

31

33

6

NOT COMPLETED

14

14

12

39

Never Treated

1

0

0

0

Adverse Event

2

0

1

1

Lack of Efficacy

11

14

11

38

Period 2: Open-Label Continuation of DB

MK0518 200 mg b.i.d.

MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

Placebo

STARTED

30

31

33

6

COMPLETED

23

21

24

5

NOT COMPLETED

7

10

9

1

Adverse Event

3

1

0

0

Lack of Efficacy

1

4

3

1

Lost to Follow-up

1

1

1

0

Withdrawal by Subject

0

1

3

0

Patient did not continue in extension

1

0

0

0

Patient moved/site stopped trial

1

3

2

0

Period 3: Open-Label Post Virologic Failure(OLPVF)

MK0518 200 mg b.i.d.

MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

Placebo

STARTED

11 [1]

13 [1]

11 [1]

37 [1]

COMPLETED

2

7

5

19

NOT COMPLETED

9

6

6

18

Adverse Event

0

0

0

1

Lack of Efficacy

7

6

5

10

Lost to Follow-up

1

0

0

1

Withdrawal by Subject

0

0

0

5

Patient moved/Site stopped trial

1

0

1

1

[1]

Number of Patients appropriate for and who consented to enter the OLPVF

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

MK0518 200 mg b.i.d.

Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

MK0518 400 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Placebo

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All patients who took study medication were included in the analysis.

Reporting Groups

Description

MK0518 200 mg b.i.d.

Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

MK0518 400 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Placebo

OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.

Measured Values

MK0518 200 mg b.i.d.

MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

Placebo

Participants Analyzed [Units: Participants]

43

45

45

45

Number of Patients That Discontinued With Serious CAEs at 48 Weeks [Units: Participants]

Discontinued With Serious CAEs

1

0

1

1

Did Not Discontinue With Serious CAEs

42

45

44

44

No statistical analysis provided for Number of Patients That Discontinued With Serious CAEs at 48 Weeks

12. Secondary:

Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Due to a 3:1 randomization of MK-0518 to placebo and more discontinuations for placebo in the doubleblind phase, exposure for MK-0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.